A Phase I Study of SGN-LIV1A in Women with Metastatic Breast Cancer

Protocol

14-013

Full Title

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients with LIV-1- Positive Metastatic Breast Cancer

Phase

I

Purpose

Researchers in this study are seeking to find the highest dose of an investigational drug called SGN-LIV1A that can be given safely in patients with metastatic breast cancer that persists despite prior therapy, and to observe its preliminary effectiveness against breast cancer.

SGN-LIV1A is an “antibody-drug conjugate.” It is comprised of an antibody (brentuximab vedotin) that binds to breast cancer cells which express (produce) the LIV1 protein, as well as a drug called monomethyl auristatin E (MMAE), which kills cancer cells. Most types of metastatic breast cancer express the LIV1 protein. Laboratory studies have shown that SGN-LIV1A can kill cancer cells.

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Patients must have metastatic breast cancer that expresses the LIV1 protein.

Patients must have metastatic triple-negative disease that has previously been treated with at least two prior regimens of chemotherapy, or metastatic ER-positive and/or PR-positive and HER2-negative disease that has previously been treated with at least two prior regimens of chemotherapy. Patients should no longer be candidates for hormonal therapy.

Patients must agree to undergo a baseline biopsy as well as periodic biopsies throughout the study.

Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.

This study is for women age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Shanu Modi at 646-888-5243.

Clinical Trials

Clinical trials can offer you access to a new, experimental treatment before it is available to most patients. Joining a clinical trial is also a way to make a valuable contribution toward the fight against cancer.